Registrations and Recertifications for Entities other than Hospitals

Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Ceiling Price Calculations

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0915-0327 can be found here:

Documents and Forms

Document Name Document Type
Form 2.1 Registrations and Recertifications for Entities other than Hospitals Form and Instruction
2.1 340B Registration CHC and FQHCLA.pdf 340B Registration CHC and FQHCLA..pdf Form and Instruction
2.2 340B Registration STD and TB.pdf 340B Registration STD and TB..pdf Form and Instruction
2.3 340B Registration-Covered Entities All Other Non-Hospita 340B Registration-Covered Entities All Other Non-Hospitals..pdf Form and Instruction
2.4 340B Recertfication STD and TB.pdf 340B Recertfication STD and TB..pdf Form
2.5 340B Recertification CHC and FQHCLA.pdf 340B Recertification CHC and FQHCLA..pdf Form
2.6 340B Recertification Covered Entities All Other Non-Hosp 340B Recertification Covered Entities All Other Non-Hospital..pdf Form
Registration CHC and FQHCLA.docx REDLINE Registration CHC and FQHCLA IC Document
Registration STD.TB.docx REDLINE Registration STD and TB IC Document
Registration All Other Entities.docx REDLINE Registration Other Entities IC Document
Recert CHC and FQHCLA.docx REDLINE Recert CHC and FQHCLA IC Document
Recert STD and TB.docx REDLINE Recert STD and TB IC Document
Recert All Other Non-Hospital.docx REDLINE Recert Other Non Hospital IC Document

Information Collection (IC) Details

IC Title:	Registrations and Recertifications for Entities other than Hospitals	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	2.1	340B Registration CHC and FQHCLA.pdf	340B Registration CHC and FQHCLA..pdf	Yes	Yes	Fillable Fileable
Form and Instruction	2.2	340B Registration STD and TB.pdf	340B Registration STD and TB..pdf	Yes	Yes	Fillable Fileable
Form and Instruction	2.3	340B Registration-Covered Entities All Other Non-Hospitals.pdf	340B Registration-Covered Entities All Other Non-Hospitals..pdf	Yes	Yes	Fillable Fileable
Form	2.4	340B Recertfication STD and TB.pdf	340B Recertfication STD and TB..pdf	Yes	Yes	Fillable Fileable
Form	2.5	340B Recertification CHC and FQHCLA.pdf	340B Recertification CHC and FQHCLA..pdf	Yes	Yes	Fillable Fileable
Form	2.6	340B Recertification Covered Entities All Other Non-Hospital..pdf	340B Recertification Covered Entities All Other Non-Hospital..pdf	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 11,069	Number of Respondents for Small Entity: 1,200

Affected Public: Private Sector	Private Sector: Not-for-profit institutions

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	19,451	13,875	5,576
Annual IC Time Burden (Hours)	6,368	3,580	2,788
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
REDLINE Registration CHC and FQHCLA	Registration CHC and FQHCLA.docx	08/12/2019
REDLINE Registration STD and TB	Registration STD.TB.docx	08/12/2019
REDLINE Registration Other Entities	Registration All Other Entities.docx	08/12/2019
REDLINE Recert CHC and FQHCLA	Recert CHC and FQHCLA.docx	08/12/2019
REDLINE Recert STD and TB	Recert STD and TB.docx	08/12/2019
REDLINE Recert Other Non Hospital	Recert All Other Non-Hospital.docx	08/12/2019

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.